Cleared Traditional

K042200 - MI PASTE

K042200 is an FDA 510(k) clearance for MI PASTE, manufactured by GC America, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K042200 · GC America, Inc. · Dental device
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Oct 2004
Decision
68d
Days
Class 1
Risk

K042200 is an FDA 510(k) clearance for the MI PASTE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on October 20, 2004 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042200

510(k) Number K042200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2004
Decision Date October 20, 2004
Days to Decision 68 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 128d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

EJR Device Classification - Class 1, General Controls

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EJR Agent, Polishing, Abrasive, Oral Cavity

All 76
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K042200.
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K040988 · Pascal Co., Inc. · Jul 2004
PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
K033785 · Discus Dental, Inc. · Jun 2004
K042200 · MI PASTE
Download PDF GC America, Inc.